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Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tummy time and parent education
Parent education only
Sponsored by
University of Indianapolis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth

Eligibility Criteria

35 Weeks - 44 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be eligible to participate in the study, participants must meet the following inclusion criteria:

  • born premature (< 37 weeks' gestation),
  • require medical care within Lurie Children's NICU, be between 35 and 44 weeks postmenstrual age.
  • Primary parent must have a working mobile device.
  • Participants must be English or Spanish speaking as primary language.

Exclusion criteria:

  • primary parent does not having a working mobile device and
  • Speaking a language other than English or Spanish.
  • Unable to be placed in the prone position,
  • Physiologically unstable for handling
  • Orally intubated or have a tracheostomy

Sites / Locations

  • Ann and Robert H. Lurie Children's Hospital of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tummy Time and Parent Education

Parent education

Arm Description

This group will receive tummy time and parent education and be encouraged to perform tummy time on their own. They will utilize the PT Pal application to record their tummy time adherence. The primary investigator performs the intervention to the participants two times a day for 10 minutes for 4 weeks.

This group will receive parent education only and utilize the PT Pal application to record their adherence. The primary caregiver will be encouraged to perform the same dosage of tummy time (2x/day, 10 minutes each, 4 weeks) and record their adherence on the PT Pal application.

Outcomes

Primary Outcome Measures

Test of Infant Motor Performance (TIMP) for motor outcome
The TIMP is a functional motor scale for newborns, including those born premature, up to infants four months corrected age, and was specifically designed for use in neonatal intensive care units (Rose & Westcott, 2005).

Secondary Outcome Measures

PT Pal Application: Adherence
The PT Pal application will be utilized to generate information back to the PI on adherence with tummy time outcomes of the prescription recommendations and thus serves as an adherence component for both the intervention and the standard care group.

Full Information

First Posted
November 20, 2018
Last Updated
March 23, 2020
Sponsor
University of Indianapolis
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03759119
Brief Title
Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm
Official Title
Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Indianapolis
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to see if tummy time and parent education helps motor development among infants born preterm. Participants will be recruited from Ann and Robert H. Lurie Children's Hospital of Chicago neonatal intensive care unit.
Detailed Description
The purpose of this randomized control trial will be to investigate the effects of a tummy time intervention, as compared to standard care, on motor outcomes among premature infants over a four-week period. Additionally, the study will measure tummy time adherence rates between groups post intervention for an additional four weeks. To meet this purpose, the following objectives will be addressed: To determine if there will be a difference in motor outcome scores on the Test of Infant Motor Performance (TIMP) among infants born preterm and utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only. To determine if there will be a difference in adherence rates (average minutes/day) between groups among infants born preterm utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a randomized controlled trial using a pretest /posttest control group design to allow for comparison between an intervention group that receives tummy time and parent education and a standard of care group that receives parent education only
Masking
Investigator
Masking Description
Outcome assessor investigator will be masked to all medical diagnoses of the infant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tummy Time and Parent Education
Arm Type
Experimental
Arm Description
This group will receive tummy time and parent education and be encouraged to perform tummy time on their own. They will utilize the PT Pal application to record their tummy time adherence. The primary investigator performs the intervention to the participants two times a day for 10 minutes for 4 weeks.
Arm Title
Parent education
Arm Type
No Intervention
Arm Description
This group will receive parent education only and utilize the PT Pal application to record their adherence. The primary caregiver will be encouraged to perform the same dosage of tummy time (2x/day, 10 minutes each, 4 weeks) and record their adherence on the PT Pal application.
Intervention Type
Behavioral
Intervention Name(s)
Tummy time and parent education
Other Intervention Name(s)
Group 1
Intervention Description
Participants will receive tummy time positioning while awake for 10 minutes two times a day. Physiological monitoring will be maintained throughout the entire intervention and the intervention will be adjusted if needed to maintain stability. Participants will also receive parent education on tummy time prior to the tummy time intervention. The primary investigator will perform the tummy time intervention. Participants will be encouraged to continue performing tummy time on their own and record their adherence via the PT Pal application.
Intervention Type
Behavioral
Intervention Name(s)
Parent education only
Other Intervention Name(s)
Group 2
Intervention Description
Participants will receive the same tummy time education as those in the intervention group and will be asked to continue the intervention on their own and record their adherence via the PT Pal application. Steps of the intervention for group 2 (standard care). Complete educational session with primary investigator. Adherence during the four-week intervention period will be measured remotely through the PT Pal® application.
Primary Outcome Measure Information:
Title
Test of Infant Motor Performance (TIMP) for motor outcome
Description
The TIMP is a functional motor scale for newborns, including those born premature, up to infants four months corrected age, and was specifically designed for use in neonatal intensive care units (Rose & Westcott, 2005).
Time Frame
Change in motor outcome will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months.
Secondary Outcome Measure Information:
Title
PT Pal Application: Adherence
Description
The PT Pal application will be utilized to generate information back to the PI on adherence with tummy time outcomes of the prescription recommendations and thus serves as an adherence component for both the intervention and the standard care group.
Time Frame
Change in adherence will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
44 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be eligible to participate in the study, participants must meet the following inclusion criteria: born premature (< 37 weeks' gestation), require medical care within Lurie Children's NICU, be between 35 and 44 weeks postmenstrual age. Primary parent must have a working mobile device. Participants must be English or Spanish speaking as primary language. Exclusion criteria: primary parent does not having a working mobile device and Speaking a language other than English or Spanish. Unable to be placed in the prone position, Physiologically unstable for handling Orally intubated or have a tracheostomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Martin, DHSc
Organizational Affiliation
University of Indianapolis
Official's Role
Study Chair
Facility Information:
Facility Name
Ann and Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25621433
Citation
Bentzley JP, Coker-Bolt P, Moreau NG, Hope K, Ramakrishnan V, Brown T, Mulvihill D, Jenkins D. Kinematic measurement of 12-week head control correlates with 12-month neurodevelopment in preterm infants. Early Hum Dev. 2015 Feb;91(2):159-64. doi: 10.1016/j.earlhumdev.2015.01.001. Epub 2015 Jan 23.
Results Reference
background
PubMed Identifier
11598602
Citation
Campbell SK, Hedeker D. Validity of the Test of Infant Motor Performance for discriminating among infants with varying risk for poor motor outcome. J Pediatr. 2001 Oct;139(4):546-51. doi: 10.1067/mpd.2001.117581.
Results Reference
background
PubMed Identifier
11552873
Citation
Lekskulchai R, Cole J. Effect of a developmental program on motor performance in infants born preterm. Aust J Physiother. 2001;47(3):169-76. doi: 10.1016/s0004-9514(14)60264-6.
Results Reference
background
PubMed Identifier
22336194
Citation
Oberg GK, Campbell SK, Girolami GL, Ustad T, Jorgensen L, Kaaresen PI. Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences. BMC Pediatr. 2012 Feb 15;12:15. doi: 10.1186/1471-2431-12-15.
Results Reference
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Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm

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